Gestational Diabetes - A Randomized, Controlled Trial PrEvention of PostPartum Diabetes Study (the PEPP Diabetes Study)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 600
- 试验地点
- 1
- 主要终点
- Diabetes mellitus type 2
研究概览
简要总结
Gestational diabetes is the most common metabolic abnormality during pregnancy. In a Swedish population 2-10% of all pregnant women are diagnosed with gestational diabetes mellitus (GDM). The frequency differs dependent of methods for screening and diagnostic references, even within Sweden. Women with GDM have about 50% risk to develop manifest type 2 diabetes (T2DM) within 20 years. Most counties in Sweden have a recommendation to follow women with GDM yearly with an examination and an oral glucose tolerance test (OGTT). Unfortunately, this recommendation often fails, partly due to limited resources at the health care units but also due to lack of compliance from the women. Often after the baby is born focus is changed from the mother to the child and only 30.7% of the women with one or more risk factors performed an OGTT, despite stipulated OGTT in local guidelines.
The diagnose GDM is under debate and Sweden has started to implement the recommendations from World Health Organisation (WHO) from 2013 with a lower cut-off for GDM, which will increase diagnostic sensitivity and consequently increase the number of women diagnosed with GDM. The plan was to conduct a randomized, clinical trial testing implementation the new recommendations in Sweden step-wise from 2018 and onwards. The recruitment is now complete and the results are expected to be published in 2021.
The overarching aim of this study is to conduct a randomized, controlled clinical trial to test the effect of a model for a lifestyle intervention in clinical practice, using technical support as well as personal, individual support. The intervention is based on the existing organisation and structure in Primary Care and would thus be inexpensive and straight-forward to implement. An additive aim is to explore background mechanisms for the development of type 2 diabetes in women with gestational diabetes.
详细描述
Survey of the field Gestational Diabetes Mellitus (GDM) is increasing in the world today and is strongly correlated to adverse outcomes both for the baby and the mother. The prevalence differs considerably depending on screening recommendations and diagnostic criteria and is increased among women with obesity. Both the mother and the child face higher health challenges, including manifest T2DM, over the years to come due to GDM. In turn, type 2 diabetes increase the risk of cardiovascular disease, nephropathy, retinopathy and neuropathy. Based on the results of the HAPO study, the International Association of Diabetes and Pregnancy Study Groups proposed new criteria for GDM in a consensus statement in 2012. Adopting a one-step strategy would at least double the number of women with the diagnose GDM. Sweden has started to implement the new diagnostic criteria step-wise in different counties. For diagnostic criteria, see Table 1.
Table 1. Diagnostic criteria for gestational diabetes
Gestational fP- glucose* 1-hour 2-hour glucose(venous) According to EASD 1991 ≥7.0 mmol/L ≥9 mmol/L
- 10mmol/L (capillary) According to WHO Since 2013 ≥5.1 mmol/L ≥10.0 mmol/L ≥8.5 mmol/L
- and 2-hour glucose after ingestion of 75g glucose after an overnight fast. *fP-glucose= fasting plasma glucose
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Gestational diabetes
- •Signed "Informed consent"
- •Will be expected to participate in ordinary child health care.
- •Access to Internet via computer, pad or phone
排除标准
- •Manifest diabetes mellitus before pregnancy.
- •Other conditions, e.g. endocrine disorders, or treatment, e.g. cortisone medication, that could affect blood glucose control
- •Suspicion of type 1 diabetes mellitus as assessed by GAD antibodies or clinical history
- •Participation in other concomitant research study that could interfere with the study parameters
- •Other disease, treatment or condition that according to the Principal Investigator precludes participation
结局指标
主要结局
Diabetes mellitus type 2
时间窗: Four years post partum
Number of women developing typ 2 diabetes
次要结局
- Insulin resistance(4 years)
- Fitness VO2max(Four years)
- Wellbeing(Four years)
- HbA1c(Four years)
- Glucose tolerance(Four years)